The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Electrosurgical Knife.
Device ID | K171158 |
510k Number | K171158 |
Device Name: | Single Use Electrosurgical Knife |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
Contact | Toshiyuki Nakajima |
Correspondent | Daphney Germain-kolawole Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-20 |
Decision Date | 2017-11-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170405645 | K171158 | 000 |
14953170405638 | K171158 | 000 |
14953170405621 | K171158 | 000 |
14953170377539 | K171158 | 000 |
14953170377515 | K171158 | 000 |
14953170377485 | K171158 | 000 |